A quarterly review of the eFiles tag report 

Total number of submissions*

*Refers to unique eFiles. This number does not account for iterations within each file.

 Total number of client tags (prior to validation) 

Tag submitting company and manufacturer distribution 

 Therapeutic area distribution

 Total number of tags deemed valid following internal review

Validated tag breakdown

Q1 PAAB Action Taken:

In one case that resulted in two tags, a piece was reviewed based on the pre-NOC Product Monograph. When the NOC was granted, the monograph had changed and no longer supported the claim in question. However, the reviewer did not identify this update and proceeded with the review. The discrepancy was later caught in a subsequent submission and addressed at that time. This incident prompted a reminder to PAAB staff during a reviewer meeting to carefully assess any changes between pre-NOC and NOC Product Monographs, as such changes may impact the validity of previously reviewed content.

Several tags also led to one-on-one follow-ups with reviewers to address, in general terms, clarity of written correspondences with respect to intent and accuracy of comments and the precision of code application. As part of this process, the team was reminded to refer to previous layouts when applicable, and to guide clients to supplemental documents when they can provide a clearer explanation of how specific code sections apply.

Reasons for not validating a tag:

We’ve observed a recurring issue with the use of the tag: “The requested revision was unclear to me even following a clarification phone call.” In several instances, no corresponding call is documented in the eFile. Please note that this tag is only valid if a call has actually occurred. Be sure to use this tag only after a clarification call has taken place.

Additionally, some tags marked as “Perceived issue with level of expertise” were deemed invalid. In these cases, the reviewers' feedback was accurate, and the resulting changes were appropriate. Upon review, it appeared that clearer explanations or more precise references to relevant guidances/advisories may have helped improve understanding for the client. Reviewers have been reminded to provide specific rationale and direction to support clarity.

Is there more information you would like to know and see in the next quarterly update? Let us know on the Forum.